Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers

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Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers.
Frykberg RG et al
Diabetes Care. 2017 May 2

 

Media Release:
Podimetrics Publishes Landmark Study Demonstrating 97% Sensitivity in Predicting Emergence of Diabetic Foot Ulcers Five Weeks Prior to Clinical Presentation
Early Detection Allows Clinicians to Intervene Sooner and May Prevent Adverse Consequences Associated With Diabetic Foot Ulcers
June 29, 2017 08:00 AM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--Podimetrics, Inc., a medtech and services company focused on the early detection and prevention of diabetic foot ulcers (DFU), announced today the publication of a landmark study in the July issue of Diabetes Care. Results demonstrate that the Podimetrics SmartMat™ detected as many as 97% of developing nontraumatic plantar foot ulcers on average five weeks before they presented clinically. Importantly, 86% of patients used the mat at least three times per week and 88% of respondents reported it being easy-to-use, suggesting that patients readily accept this practical, new monitoring technology.

“The Podimetrics Remote Temperature Monitoring System™ could have huge benefits for patients with diabetes who are at high risk by significantly reducing morbidity and mortality associated with diabetic foot ulcers, which could also lead to improvements in resource utilization,” said Dr. Robert Frykberg, Chief of the Podiatry Section in the Dept. of Surgery at the Carl T. Hayden Veterans Affairs Medical Center and Professor at the University of Arizona College of Medicine, Phoenix, and lead investigator.

“These data reinforce our belief that the Podimetrics Remote Temperature Monitoring System™, which consists of a wireless SmartMat™ for the home and a full monitoring and notification service, may allow earlier detection of DFU and significant improvements in care,” said Jon Bloom, MD, CEO of Podimetrics. “When we developed our system, it was clear that patients wanted an easy-to-use, in-home solution. This study demonstrates that patients find the Podimetrics SmartMat™ easy-to-use and that 86% of the population used it at least three times per week on average - which is critical for adherence and ultimately achieving ongoing prevention of DFU and its devastating complications.”

Study Design and Results
The study was a 34-week, multi-center evaluation of the Podimetrics Remote Temperature Monitoring System™ in 129 participants with diabetes and prior DFU. The primary outcome of interest was development of nontraumatic plantar DFU, and the primary efficacy analysis was the accuracy of the Podimetrics SmartMat™ for predicting the occurrence of DFU over several temperature asymmetry thresholds.

Of the 129 participants who contributed evaluable data to the study, a total of 37 (28.7%) presented with 53 DFU (0.62 DFU/participant/year). At a temperature asymmetry threshold of 2.22°C, which is the standard threshold used in previous plantar thermometry studies, the system correctly identified 97% of observed DFU, with an average lead time of 37 days. Increasing the temperature threshold to 3.20°C decreased sensitivity to 70% but reduced the false-positive rate from 57% to 32% with approximately the same lead time of 35 days. Approximately 86% of the cohort used the system at least 3 days a week on average over the study.

“The false positive rate observed in this study was not surprising or concerning,” continued Dr. Frykberg. “This is particularly true given that the value of preventing a foot ulcer and its complications far outweighs the nuisance factor of a false alert. In a real-world setting, when a doctor gets a notification that a patient has a hotspot, the patient will be advised to reduce physical activity for a period to let the developing wound heal or may be asked to come in for a visit in serious cases. Even at the most sensitive setting presented in the study, these results translate to only 3.1 total notifications to the physician and patient per year, including all true and false positives.”

The Podimetrics Remote Temperature Monitoring System™
The Podimetrics Remote Temperature Monitoring System™ consists of a wireless SmartMat™ for the home and a monitoring service that notifies patients and clinicians when signs of inflammation may be developing. To use the system, a patient stands on the mat for 20 seconds per day at home. Patient data is sent instantly to the cloud, where the Podimetrics system automatically measures the temperature difference between the feet at various locations looking for a possible persistent asymmetry, or “hotspot.” It has been well established that these hotspots strongly correlate with the eventual development of a foot ulcer. If a developing hotspot is detected, the healthcare provider is notified based on their custom protocol. From there an intervention is planned by the physician. Most interventions require a patient to stay off his/her feet while the foot heals itself. If the readout is persistent or more concerning, the patient may visit their doctor to take more aggressive preventative steps.

The Podimetrics system is easy-to-use for healthcare providers as the solution is tailored to meet the needs of each specific care environment via close collaboration.

About Diabetic Foot Ulcers
Diabetic Foot Ulcers (DFU) are common and expensive complications of diabetes which can result in amputation in serious cases. Approximately 1.7 million Americans suffer from one or more DFU each year. Though all patients with diabetes are at risk for developing a DFU, those patients who have recently healed from a previous DFU episode have approximately a 40% likelihood of recurrence in the first year after closure. It is estimated that direct costs associated with DFU exceed $17 billion annually.

About Podimetrics
Podimetrics is a medtech and services company focused on the commercialization of next-generation hardware-enabled, thermo-imaging solutions for the prediction and prevention of diabetic foot ulcers. The Podimetrics SmartMat™ is the only remote temperature monitoring technology that has received FDA clearance, and has been in over 650 patient homes. The Podimetrics Remote Temperature Monitoring System™ consists of a wireless SmartMat™ for the home and a monitoring service that notifies patients and clinicians when temperature asymmetry presents between the two feet, a potential sign of inflammation and a developing foot ulcer. Podimetrics was formed out of the Massachusetts Institute of Technology in 2011 and is based in Somerville, MA.

 

The mat:

 

Press Release:
Podimetrics Raises $13.4 Million to Expand Innovative Solution for
Diabetes Complications
Investment will accelerate the company's business development among VA hospitals and
commercial payers
SOMERVILLE, Mass., May 9, 2019 -- Podimetrics, a care management company with the
leading solution to help prevent costly and deadly diabetic foot ulcers (DFUs), today announced
it has closed a $13.4 million Series B funding round. Participants included Rock Health, Norwich
Ventures, and Scientific Health Development. The new funding will accelerate Podimetrics’
growing presence within the Veterans Affairs (VA) health care system and commercial payers
nationwide.
“Diabetic foot ulcers are one of the most devastating and costliest diabetes-related
complications. In fact, data suggest that today as many as one out of every three dollars spent
on diabetes is linked to lower extremity complications,” said Podimetrics co-founder and CEO
Dr. Jon Bloom. “At Podimetrics, we are working diligently to help prevent DFUs, remotely
catching early signs often five weeks before they would present clinically. As the son of a
veteran, it is gratifying to know this funding will accelerate our efforts to bring this solution to
more patients, especially in the VA system.”
With Podimetrics, patients simply place their feet on a cellular-connected SmartMat for just 20
seconds a day. The data is then seamlessly and automatically sent to the Podimetrics care
team, which triages any concerning findings to help patients receive appropriate, preventive
treatments under the direction of their clinician. While DFUs are but one complication of
diabetes, they have a devastating effect on patients’ lives, leading to debilitating injuries and
amputations, and they are a significant driver of health care costs -- a single DFU-related
amputation costs on average $100,000.
Podimetrics will use the funding to continue growing its business within the VA, where one out
of every four veterans has diabetes and 80 percent of non-traumatic amputations are from a
DFU. The VA recently released a national guidance document recommending Podimetrics for
high-risk patients. Additionally, the company will continue to grow its business among
commercial payers.
"We continue to be impressed by the clinical outcomes delivered by the Podimetrics platform,
which has been achieved by integrating proprietary remote monitoring technology with a
proactive care management program," said Rock Health Venture Principal Jeff Trost. "We are
excited to support Podimetrics as they scale and bring this clinically validated solution to the
millions of patients who can live healthier lives free of DFUs.”
Podimetrics was founded in 2011 by a physician and engineers from MIT and Harvard. Its
SmartMats are FDA-cleared, have the American Podiatric Medical Association Seal of Approval,
and are manufactured in Massachusetts.

 

Digital foot health technology and diabetic foot monitoring: A systematic review
ClaireSalib et al
Diabetes Research and Clinical Practice Volume 175, May 2021, 108783